Multi-vial adapters for reconstituting or diluting lyophilized or concentrated drug products

Abstract

The present disclosure is directed to adapters for mixing vials of drug products, and more specifically to multi-vial adapters for reconstituting lyophilized drug products and/or diluting concentrated drug products. It is an object to address one or more of drawbacks in connection with the drug preparation process, for example, by simplifying the procedure where multiple vials are required to be diluted or reconstituted in a serial manner. As such, the multi-vial adapters described herein simplify the complexity of preparing and handling multiple vials of drug product, which significantly reduces preparation time, addresses dosing-related challenges like weight-based preparation, reduces drug waste issues, and reduces risks associated sterility and contamination, among other benefits.

What is claimed is: 
     
         1 . A method of reconstituting or diluting a lyophilized or concentrated drug product using a multi-vial adapter, the method comprising:
 connecting at least a first diluent source containing a diluent liquid to a primary interface of the multi-vial adapter;   connecting two or more drug product vials containing a lyophilized and/or concentrated drug product to a respective secondary interface of the multi-vial adapter, wherein the respective secondary interfaces are fluidly connected in parallel with the primary interface via a plurality of fluid paths defined through the multi-vial adapter;   transferring the diluent liquid from at least the first diluent source to the two or more drug product vials via the plurality of fluid paths through the multi-vial adapter; and   withdrawing, using a drug delivery device, a reconstituted and/or diluted drug solution from the two or more drug product vials via the plurality of fluid paths defined through the multi-vial adapter.   
     
     
         2 . The method of  claim 1 , wherein the plurality of fluid paths are configured to enable a simultaneous fluid flow of the diluent liquid from at least the first diluent source received by the primary interface to the two or more drug products vials received by the respect secondary interfaces. 
     
     
         3 . The method of  claim 1 , wherein the first diluent source is either a diluent vial or a pre-filled syringe. 
     
     
         4 . The method of  claim 1 , further comprising:
 attaching the drug delivery device to an outlet interface of the multi-vial adapter, wherein the outlet interface is fluidly connected to the plurality of fluid paths defined through the multi-vial adapter.   
     
     
         5 . The method of  claim 4 , wherein the drug delivery device is a syringe and the outlet interface is configured to attached to the syringe. 
     
     
         6 . The method of  claim 4 , wherein the outlet interface is also the primary interface. 
     
     
         7 . The method of  claim 1 , wherein the reconstituted and/or diluted drug solution is withdrawn simultaneously from the two or more drug product vials via the plurality of fluid paths defined through the multi-vial adapter. 
     
     
         8 . The method of  claim 1 , wherein:
 at least the first diluent source is a diluent vial;   the primary interface of the multi-vial adapter comprises one or more securing mechanisms and one or more hollow needles disposed therein; and   at least the first diluent source is connected to the multi-vial adapter via the primary interface such that the one or more securing mechanisms engage a top of the diluent vial to securely retain the diluent vial and the one or more hollow needles puncture the top of the diluent vial.   
     
     
         9 . The method of  claim 1 , wherein:
 each of the respective secondary interfaces of the multi-vial adapter comprise one or more securing mechanisms and one or more hollow needles disposed therein; and   the two or more drug product vials are connected to the respective secondary interfaces such that the one or more securing mechanisms engage a top of each drug product vial to securely retain the drug product vial and the one or more hollow needles puncture the top of the drug product vial.   
     
     
         10 . The method of  claim 9 , wherein the one or more hollow needles disposed within the secondary interfaces have tips configured to divert a fluid flow from the diluent source towards an interior side wall of a corresponding drug product vial. 
     
     
         11 . The method of  claim 1 , wherein the plurality of fluid paths are configured such that approximately equal volumes of liquid from the diluent source flow into each of the two or more drug product vials connected at the respective secondary interfaces. 
     
     
         12 . The method of  claim 1 , further comprising:
 inverting the multi-vial adapter and the first diluent source connected thereto prior to connecting the two or more drug product vials.   
     
     
         13 . The method of  claim 1 , further comprising:
 inverting the multi-vial adapter and the two or more drug product vials connected thereto prior to withdrawing the reconstituted and/or diluted drug solution from the two or more drug product vials.   
     
     
         14 . The method of  claim 1 , wherein the plurality of fluid paths comprises:
 a first fluid manifold fluidly connecting the primary interface with the respective secondary interfaces; and   a second fluid manifold fluidly connecting the respective secondary interfaces to an outlet interface of the multi-vial adapter.   
     
     
         15 . The method of  claim 1 , wherein the multi-vial adapter further comprises a pressure release path that connects ambient atmosphere with the primary interface. 
     
     
         16 . The method of  claim 15 , wherein the multi-vial adapter further comprises a second hollow needle disposed within the primary interface that is fluidly connected to the pressure release path, the second hollow needle being configured to puncture a top of the diluent source when received by the primary interface and thereby enable air from the ambient atmosphere to enter the diluent source. 
     
     
         17 . The method of  claim 16 , wherein the multi-vial adapter further comprises a filter disposed within the pressure release path, the filter configured to prevent solid particulates from entering the diluent source via the pressure release path when received by the primary interface. 
     
     
         18 . The method of  claim 1 , wherein the multi-vial adapter comprises a detachable diluent member that forms the primary interface, and the detachable diluent member is configured to attach to an outlet interface of the multi-vial adapter such that the primary interface is fluidly connected with the plurality of fluid paths. 
     
     
         19 . The method of  claim 18 , further comprising:
 detaching the diluent member from the outlet interface along with the first diluent source after transferring the diluent liquid to the two or more drug product vials.   
     
     
         20 . The method of  claim 1 , wherein transferring the diluent liquid from at least the first diluent source to the two or more drug product vials forms the reconstituted and/or diluted drug solution within the two or more drug product vials, and
 wherein the diluent liquid is transferred from at least the first diluent source through the plurality of fluid paths and to the two or more drug product vials via gravity.